Ulcerative ColitisSKIPONCT02110862
Scintigraphic Evaluation of IPAA Function in Patients With Ulcerative Colitis
An observational study of Ulcerative Colitis, run by Odense University Hospital at 1 site in Denmark.
Trial summary
The aim of this study is to evaluate scintigraphic methods as objective factors for functional outcome in patients treated with ileal-pouch-anal anastomosis (IPAA). The gastrointestinal transit-time and the degree of evacuation are evaluated in relation to the functional outcome. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Transittime. Defecography
- How many people
- 21 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2012to Aug 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Ulcerative colitis
Who may be able to join
- Ulcerative colitis patients
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Scintigraphic Evaluation of IPAA Function in CU Patients
The aim of this study is to evaluate scintigraphic methods as objective factors for functional outcome in patients treated with ileal-pouch-anal anastomosis (IPAA). The gastrointestinal transit-time and the degree of evacuation are evaluated in relation to the functional outcome.
- Conditions
- Ulcerative Colitis
- Being tested
- Transittime. Defecography
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transittime. DefecographyOther
| Study group | Role | What they receive |
|---|---|---|
| Ulcerative colitis patients with ileal-pouch-anal anastomosis | Not described Receives: Other: Transittime. Defecography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal transit-time
The small bowel transittime until food is in the IPAA
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2014 (estimated)
- Study startJan 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mie Dilling Kjaer, Odense University Hospital
- Investigators
- Mie Kjaer, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02110862
- Sponsor's protocol ID
- Skipo-2013
- Other IDs
- S-20110117
- Acronym
- SKIPO
- Status last verified
- Jan 2016
- First submitted
- 30 Apr 2013
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scintigraphic Evaluation of IPAA Function in CU Patients
- ClinicalTrials.gov ID
- NCT02110862
- Acronym / sponsor ID
- SKIPO / Skipo-2013
- Conditions
- Ulcerative Colitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 10 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate scintigraphic methods as objective factors for functional outcome in patients treated with ileal-pouch-anal anastomosis (IPAA). The gastrointestinal transit-time and the degree of evacuation are evaluated in relation to the functional outcome.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ulcerative colitis patients with ileal-pouch-anal anastomosis | – | Other: Transittime. Defecography |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ulcerative colitis
Key inclusion criteria (1 listed)
- Ulcerative colitis patients
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transittime. Defecography | Other | Ulcerative colitis patients with ileal-pouch-anal anastomosis |
Primary outcome
Gastrointestinal transit-time
Time frame: 12 weeks
The small bowel transittime until food is in the IPAA
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mie Kjaer principal investigator
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal transit-time (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2016.